1.Compilation Instruction and Key Point Interpretation for Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration
Wenzhe LI ; Rui MA ; Xiaoxiao ZHAO ; Hong HUA ; Xin CUI ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):260-266
To develop the Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration in response to common problems, including insufficient safety information in package inserts, amplified medication risks in special populations, and non-standard clinical practices, thus establishing a risk management system tailored to the characteristics of Chinese patent medicines for mucosal administration. An approach combining qualitative and quantitative methods was adopted. In accordance with the Drug Administration Law of the People's Republic of China (2019 revision) and the GB/T 1.1—2020 standard, a systematic search was performed in the Chinese Pharmacopoeia (2020 edition), the Catalog of Medicines Covered by Medical Insurance (2022 edition), Chinese databases [China Network of Knowledge Infrastructure (CNKI), Wanfang Data (Wanfang), and VIP journal resource integration service platform (VIP)], and international databases (Cochrane Library, PubMed, and EMbase). Guideline outlines were developed through questionnaire surveys, expert interviews, and the nominal group technique. The content of each item was formulated with full consideration of traditional Chinese medicine (TCM) incompatibility, as well as the conceptual connotations and extensions of pharmacovigilance. The results included 54 Chinese patent medicines for mucosal administration from the Chinese Pharmacopoeia (2020 edition) and 58 from the Catalog of Medicines Covered by Medical Insurance (2022 edition). Safety-related items in the corresponding package inserts were collected, and 27 relevant publications were retrieved. Thirty experts from 24 institutions were mobilized for the drafting, and opinions from 61 external experts were solicited. A pharmacovigilance framework was established, covering the full chain of "monitoring, identification, assessment, and control". Based on seven anatomical sites, including nasal, ocular, and oral mucosa, a stratified monitoring system was constructed. The guideline proposed key recommendations on improving package insert sections such as "Adverse Reactions", "Contraindications", and "Precautions", clinical procedure standardization in healthcare institutions, risk control, and dynamic pharmacovigilance. The Guideline provides evidence-based support tailored to the risk profile of Chinese patent medicines for mucosal administration, filling the current gap in international pharmacovigilance standards in this field, while offering technical support for safety management across the full life cycle of medicines for mucosal administration.
2.Compilation Instruction and Key Point Interpretation for Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration
Wenzhe LI ; Rui MA ; Xiaoxiao ZHAO ; Hong HUA ; Xin CUI ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):260-266
To develop the Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration in response to common problems, including insufficient safety information in package inserts, amplified medication risks in special populations, and non-standard clinical practices, thus establishing a risk management system tailored to the characteristics of Chinese patent medicines for mucosal administration. An approach combining qualitative and quantitative methods was adopted. In accordance with the Drug Administration Law of the People's Republic of China (2019 revision) and the GB/T 1.1—2020 standard, a systematic search was performed in the Chinese Pharmacopoeia (2020 edition), the Catalog of Medicines Covered by Medical Insurance (2022 edition), Chinese databases [China Network of Knowledge Infrastructure (CNKI), Wanfang Data (Wanfang), and VIP journal resource integration service platform (VIP)], and international databases (Cochrane Library, PubMed, and EMbase). Guideline outlines were developed through questionnaire surveys, expert interviews, and the nominal group technique. The content of each item was formulated with full consideration of traditional Chinese medicine (TCM) incompatibility, as well as the conceptual connotations and extensions of pharmacovigilance. The results included 54 Chinese patent medicines for mucosal administration from the Chinese Pharmacopoeia (2020 edition) and 58 from the Catalog of Medicines Covered by Medical Insurance (2022 edition). Safety-related items in the corresponding package inserts were collected, and 27 relevant publications were retrieved. Thirty experts from 24 institutions were mobilized for the drafting, and opinions from 61 external experts were solicited. A pharmacovigilance framework was established, covering the full chain of "monitoring, identification, assessment, and control". Based on seven anatomical sites, including nasal, ocular, and oral mucosa, a stratified monitoring system was constructed. The guideline proposed key recommendations on improving package insert sections such as "Adverse Reactions", "Contraindications", and "Precautions", clinical procedure standardization in healthcare institutions, risk control, and dynamic pharmacovigilance. The Guideline provides evidence-based support tailored to the risk profile of Chinese patent medicines for mucosal administration, filling the current gap in international pharmacovigilance standards in this field, while offering technical support for safety management across the full life cycle of medicines for mucosal administration.
3.Early screening strategies for metabolic associated fatty liver disease
Kaiye HUA ; Mengfan JIA ; Yingwei ZHU ; Zhonghua LU ; Jian LU ; Hong TANG
Journal of Clinical Hepatology 2026;42(2):420-426
Metabolic associated fatty liver disease (MAFLD) is a common chronic liver disease worldwide, and timely and precise intervention can delay disease progression and significantly reduce the risk of serious complications such as liver fibrosis, liver cirrhosis, and liver cancer. Although traditional liver biopsy combined with metabolic markers is the gold standard, it may cause complications such as pain and bleeding as an invasive examination, which has promoted scientific research to shift its focus to the construction of noninvasive assessment systems. In recent years, noninvasive diagnostic technologies based on multi-dimensional detection strategies have been continuously updated, including serological models, imaging techniques, and clinical algorithms. This article systematically reviews the screening methods for MAFLD during the fibrotic stages F1—F3, especially deep learning models based on artificial intelligence, in order to provide ideas for the early screening of MAFLD, as well as a scientific reference for optimizing disease management strategies.
4.Advances in the application of digital technology in orthodontic monitoring
WANG Qi ; LUO Ting ; LU Wei ; ZHAO Tingting ; HE Hong ; HUA Fang
Journal of Prevention and Treatment for Stomatological Diseases 2025;33(1):75-81
During orthodontic treatment, clinical monitoring of patients is a crucial factor in determining treatment success. It aids in timely problem detection and resolution, ensuring adherence to the intended treatment plan. In recent years, digital technology has increasingly permeated orthodontic clinical diagnosis and treatment, facilitating clinical decision-making, treatment planning, and follow-up monitoring. This review summarizes recent advancements in digital technology for monitoring orthodontic tooth movement, related complications, and appliance-wearing compliance. It aims to provide insights for researchers and clinicians to enhance the application of digital technology in orthodontics, improve treatment outcomes, and optimize patient experience. The digitization of diagnostic data and the visualization of dental models make chair-side follow-up monitoring more convenient, accurate, and efficient. At the same time, the emergence of remote monitoring technology allows orthodontists to promptly identify oral health issues in patients and take corresponding measures. Furthermore, the multimodal data fusion method offers valuable insights into the monitoring of the root-alveolar relationship. Artificial intelligence technology has made initial strides in automating the identification of orthodontic tooth movement, associated complications, and patient compliance evaluation. Sensors are effective tools for monitoring patient adherence and providing data-driven support for clinical decision-making. The application of digital technology in orthodontic monitoring holds great promise. However, challenges like technical bottlenecks, ethical considerations, and patient acceptance remain.
5.Study on the antibacterial property of EGCG/PLL phenolamine coating integrated chlorhexidine on porous titanium surface
Huilei Hong ; Jianguang Xu ; Hua Qiu
Acta Universitatis Medicinalis Anhui 2025;60(1):109-116
Objective:
To construct a phenolamine cross-linked coating composed of epigallocatechin gallate(EGCG) and poly-L-lysine(PLL) on the surface of the porous pure Ti integrated with the antibacterial substance chlorhexidine(CHX), and to study the antibacterial property and biosafety.
Methods:
A porous structure(pTi group) was formed on the surface of titanium samples by alkaline heat treatment. Then the pTi group was immersed in the mixed solution of EGCG and PLL in an alkaline aerobic environment for 24 h to obtain the phenolamine group samples(EP group). Finally, the titanium tablets were further immersed in the aqueous solution of chlorhexidine(CHX) for 24 h to obtain the antibacterial groups(EPC group). Microstructure and properties of the surface were characterized by scanning electron microscopy(SEM), X-ray photoelectron spectrometer(XPS) and water contact angle measuring instrument. The antibacterial properties of coating were observed and evaluated by nephelometry, inhibition zone method and live/dead bacterial staining. The cytocompatibility of the coating was evaluated by MTT method and cell fluorescence staining, and the cell adhesion and proliferation ability in bacterial environment were evaluated by the co-culture of bacteria and cells.
Results:
SEM results showed that the pore size of samples after alkali heat treatment decreased with the deposition of the phenolamine coating. The measurement of water contact angle showed that the contact angle increased significantly with the grafting of coating. The intensity of N1s and C1s peaks increased and Ti2p and O1s peaks decreased detected by XPS tests. The Cl2p peak appeared in EPC group referred to the control group. The antibacterial experimentsin vitroshowed that the antibacterial samples could perform effective antibacterial effects on Staphylococcus aureus and Aggregatibacter actinomycetem-comitans for at least 7 days. In the biocompatibility experiments, MTT and cell fluorescence staining results showed that the adherent cells had good morphology and proliferative activity. The bacteria-cell co-culture results showed that the EPC groups could provide a good environment for cell proliferation and growth with excellent antibacterial properties.
Conclusion
Chlorhexidine-grafted phenolamine deposited on porous titanium surface displays an effective antibacterial effect with good biosafety performance, which can play an antibacterial role in the bacterial environment while ensuring cell adhesion and proliferation.
6.Controllability Analysis of Structural Brain Networks in Young Smokers
Jing-Jing DING ; Fang DONG ; Hong-De WANG ; Kai YUAN ; Yong-Xin CHENG ; Juan WANG ; Yu-Xin MA ; Ting XUE ; Da-Hua YU
Progress in Biochemistry and Biophysics 2025;52(1):182-193
ObjectiveThe controllability changes of structural brain network were explored based on the control and brain network theory in young smokers, this may reveal that the controllability indicators can serve as a powerful factor to predict the sleep status in young smokers. MethodsFifty young smokers and 51 healthy controls from Inner Mongolia University of Science and Technology were enrolled. Diffusion tensor imaging (DTI) was used to construct structural brain network based on fractional anisotropy (FA) weight matrix. According to the control and brain network theory, the average controllability and the modal controllability were calculated. Two-sample t-test was used to compare the differences between the groups and Pearson correlation analysis to examine the correlation between significant average controllability and modal controllability with Fagerström Test of Nicotine Dependence (FTND) in young smokers. The nodes with the controllability score in the top 10% were selected as the super-controllers. Finally, we used BP neural network to predict the Pittsburgh Sleep Quality Index (PSQI) in young smokers. ResultsThe average controllability of dorsolateral superior frontal gyrus, supplementary motor area, lenticular nucleus putamen, and lenticular nucleus pallidum, and the modal controllability of orbital inferior frontal gyrus, supplementary motor area, gyrus rectus, and posterior cingulate gyrus in the young smokers’ group, were all significantly different from those of the healthy controls group (P<0.05). The average controllability of the right supplementary motor area (SMA.R) in the young smokers group was positively correlated with FTND (r=0.393 0, P=0.004 8), while modal controllability was negatively correlated with FTND (r=-0.330 1, P=0.019 2). ConclusionThe controllability of structural brain network in young smokers is abnormal. which may serve as an indicator to predict sleep condition. It may provide the imaging evidence for evaluating the cognitive function impairment in young smokers.
7.Effects of Ningxin Shugan Decoction Combined with Antagonist Fixation Regimen on IVF-ET Outcomes and Serum Kisspeptin Expression in Infertility Patients with Polycystic Ovary Syndrome
Hua FENG ; Dan XU ; Xuelan HONG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(5):177-184
ObjectiveTo investigate the effects of Ningxin Shugan decoction combined with an antagonist fixation regimen on in vitro fertilization and embryo transfer (IVF-ET) outcomes and serum kisspeptin expression in infertility patients with polycystic ovary syndrome. MethodsA total of 96 infertile patients with polycystic ovary syndrome treated in Yancheng No.1 People's Hospital and Yancheng Affiliated Hospital of Nanjing University of Chinese Medicine were enrolled in this study and randomized into control and observation groups (n=48). The control group was treated with an antagonist fixation regimen, and the observation group was treated with Ningxin Shugan decoction on the basis of the treatment in the control group. The clinical efficacy was compared between the two groups. The total score and single scores of TCM symptoms, ovulation promotion status, and serum levels of reproductive hormones, miR-335-5p, miR-141-3p, and kisspeptin were determined before and after treatment. The IVF-ET outcome indicators and treatment safety were evaluated. Pearson test was conducted to analyze the correlations of serum levels of follicle-stimulating hormone (FSH), kisspeptin, miR-335-5p, and miR-141-3p with IVF-ET outcomes. ResultsThe total response rate in the observation group was 90.91%, which was higher than that (70.45%) in the control group (P<0.05). The total score and single scores of TCM symptoms and the testosterone, luteinizing hormone (LH), and LH/FSH levels declined after treatment (P<0.05), and they were lower in the observation group than in the control group (P<0.05). After treatment, the serum levels of FSH, kisspeptin, miR-335-5p, and miR-141-3p rose in both groups, being higher in the observation group than in the control group (P<0.05). The observation group showed higher ovulation number, number of MⅡ oocytes, embryo implantation rate, clinical pregnancy rate, and live birth rate than the control group (P<0.05, P<0.01). Serum levels of FSH, kisspeptin, miR-335-5p, and miR-141-3p were positively correlated with embryo implantation rate, clinical pregnancy rate, and live birth rate (P<0.01). ConclusionNingxin Shugan decoction combined with the antagonist fixation regimen can improve the IVF-ET outcome, promote the serum kisspeptin expression, and increase the ovulation rate and pregnancy rate in infertility patients with polycystic ovary syndrome.
8.Psychodrama group therapy based on family parenting intervention for parents of adolescents with depressive disorder: a qualitative study
Hong CHEN ; Lijun CHA ; Yuhan WANG ; Xiaohong YANG ; Hua HU
Sichuan Mental Health 2025;38(2):102-107
BackgroundFamily factors are known to play a critical role in the development, progression and prognosis of adolescent patients with depressive disorder. Psychodrama group therapy has the potential for bringing about positive change in individual growth and relationship repair, but there is currently insufficient research evidence for the effectiveness of psychodrama group therapy in promoting the recovery in depressive disorder in adolescents through improving the family parenting skills of their parents. ObjectiveTo explore the influence of psychodrama group therapy based on family parenting intervention on parents of adolescent patients with depressive disorder, so as to provide references for promoting the recovery for adolescent patients with depressive disorder. MethodsPurposive sampling was used to recruit adolescent patients who met the diagnostic criteria for depressive disorder of the International Classification of Diseases, tenth edition (ICD-10) and hospitalized in the psychiatric outpatient department of the First Affiliated Hospital of Chongqing Medical University from October 2023 to March 2024, and their parents (either mother or father) were taken as the study subjects. Psychodrama group therapy based on family parenting intervention was performed once a week for 6 consecutive weeks. After intervention, semi-structured interviews were conducted with parents who participated in the group, and the interviews were recorded. Content analysis method was employed to perform qualitative analysis on the interview recordings and verbatim transcripts. ResultsAfter receiving psychodrama group intervention based on family parenting, parents of adolescent patients with depressive disorder demonstrated improvement in emotional state, enhanced reflective ability and altered coping style, which were specifically manifested as reducing negative emotions, increasing positive emotions, reflecting on themselves, empathizing with others, adjusting cognition, changing the way of stress regulation, improving communication styles and actively seeking resources. ConclusionApplication of psychodrama group therapy based on family parenting intervention may improve emotional state, reflective ability and coping style of the parents of adolescent patients with depressive disorder. [Funded by Chongqing Education Commission Humanities and Social Science Research Project (number, 19SKGH018); Chongqing Social Science Planning Project (number, 2021WT29)]
9.Relevance between parental psychological control and Internet gaming disorder in middle school students
WANG Xi, JIANG Hong, WANG Lina, ZHANG Hua, ZHANG Wei, MA Le
Chinese Journal of School Health 2025;46(4):544-547
Objective:
To analyze the relationship between parental psychological control and Internet Gaming Disorder (IGD) among junior high school students, so as to provide evidence for preventing IGD development in adolescents.
Methods:
From August 2019 to February 2020, a survey was conducted among 1 169 junior high school students from three middle schools in Xian using stratified cluster sampling. The Parental Psychological Control Scale and IGD Scale were administered to assess parental psychological control and IGD prevalence. Univariate and binary Logistic regression analyses were used to explore IGD risk factors and their correlation with parental psychological control.
Results:
The detection rate of IGD in middle school students was 19.9%(184/1 169). Multivariate Logistic regression revealed that compared to those with lower parental psychological control scores(≤21 points), students with higher parental psychological control scores (>21 points) had a higher risk of IGD (OR=1.82, 95%CI=1.21-2.74), a 1.58fold higher risk of selfperceived gaming addiction (95%CI=1.07-2.30), as well as reduced likelihood of seeking external help to reduce gaming time (OR=0.66, 95%CI=0.47-0.94) (P<0.05).
Conclusions
Parental psychological control may elevate the risks of IGD and selfperceived addiction while diminishing proactive helpseeking behaviors to reduce gaming time. Parents should enhance communication with adolescents and provide positive guidance to mitigate potential gamingrelated harms.
10.Health risk assessment of per- and polyfluoroalkyl substances contamination in animal-derived foods in Shanghai
Chenlin GU ; Jingjin YANG ; Baozhang LUO ; Danping QIU ; Hong LIU ; Hua CAI
Shanghai Journal of Preventive Medicine 2025;37(7):556-561
ObjectiveTo analyze the current status of per⁃ and polyfluoroalkyl substances (PFASs) contamination in animal⁃derived foods in Shanghai and to assess the risk of dietary exposure among local residents, thereby providing a scientific basis for future dietary safety and risk management. MethodsA total of 300 commonly consumed animal⁃derived food samples were collected in Shanghai in 2023 and tested for 17 types of PFASs. Based on local dietary consumption data, the weekly exposure intake (EWI) of four representative PFASs was calculated using the exposure assessment model recommended by Food and Agriculture Organization (FAO) and the World Health Organization (WHO). The calculated EWI was compared with the tolerable weekly intake (TWI) set by the European Food Safety Authority (EFSA) to assess the health risks associated with dietary intake of PFASs. ResultsThe predominant PFASs detected in aquatic products were PFUnDA (98.67%), PFTrDA (98.00%), and PFOS (95.33%), with PFUnDA having the highest median mass fraction (0.378 ng·g-1). In meat samples, PFBA (54.17%), PFOA (20.83%), and PFOS (18.33%) were mainly detected, with PFBA showing the highest median mass fraction (0.027 ng·g-1). In egg samples, the most frequently detected compounds were PFBA (90.00%), PFOA (63.33%), PFOS (50.00%), PFDA (50.00%), PFNA (50.00%), and PFHxDA (50.00%), with PFBA again having the highest median mass fraction (0.068 ng·g-1). The median mass fractions of the four key PFASs (PFOA, PFOS, PFNA, and PFHxS) in aquatic products were significantly higher than those in meat products and eggs (all P<0.001), and there were statistically significant differences in the median mass fractions of the four PFASs among different types of aquatic products (all P<0.05). The EWI of the four PFASs was 2.970 ng·kg-1 for the mean consumption group and 6.676 ng·kg-1 for the high consumption group (P95), with females having higher EWI values than males. ConclusionPFOS, PFOA, and PFBA are the major PFAS contaminants in animal⁃derived foods consumed by Shanghai residents, with aquatic products having the highest levels of contamination. The EWIs of four PFASs among Shanghai residents did not exceed EFSA’s recommended TWI at average consumption levels. However, the EWIs for high⁃consumption populations exceeded the EFSA⁃recommended TWI, posing potential health risks to these populations. Aquatic products contribute the most to dietary PFAS exposure. It is necessary to strengthen PFAS monitoring in aquatic products and conduct targeted risk assessments for high⁃consumption groups.


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